The anti-epileptic therapy is a purified form of cannabidiol (CBD), the most abundant non-psychoactive cannabinoid compound in the cannabis plant. CBD can mimic natural compounds that act on brain receptors, which when faulty can cause seizures.

“We are delighted to announce that Epidolex is now available by physician prescription as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy,” Justin Gover, chief executive officer of GW Pharmaceuticals, said in a press release.

“Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures,” he said.

To support patients’ access to the therapy, GW Pharmaceuticals launched a program — Epidolex Engage — that offers guided resources for patients and caregivers, helping those with financial constraints get access to the therapy. Also, eligible patients may have access to the product at no cost.

“We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients,” Gover said.

The extension study evaluated the long-term safety and effectiveness of Epidiolex and included 189 Dravet patients from two of the previous Phase 3 trials. Results showed that treatment with Epidiolex reduced convulsive seizures by 38-44% and all seizures by 39-51%.

Treatment also improved overall health and clinical status in roughly 80% of patients at six months and one year of treatment.

“We are very pleased that Epidolex — the first medication to be approved by the FDA for patients with Dravet syndrome — is now available,” said Mary Anne Meskis, executive director of the Dravet Syndrome Foundation. “Our community has long desired a medication specifically approved for the treatment of seizures associated with Dravet syndrome, and the availability of Epidolex is an important milestone for patients and caregivers whose lives are significantly impacted by this catastrophic, lifelong form of epilepsy.”

The therapies available to patients with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy, are also limited.

“Despite the use of multiple epilepsy treatments, the majority of LGS patients continue to have lifelong, debilitating seizures and our community welcomes the availability of a new, first-in-class treatment option,” she said.

Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.

Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.

Disclaimer:

Dravet Syndrome News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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